Condition category
Eye Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs M Nagar

ORCID ID

Contact details

Consultant Ophthalmologist
The Mid Yorkshire Hospitals NHS Trust
Clayton eye Centre
Clayton Hospital
Wakefield
WF1 4EE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0183168499

Study information

Scientific title

Acronym

Study hypothesis

What is the effect of selective laser trabeculoplasty and Xalatan eye drops on intra-ocular pressure fluctuation?
An earlier study (see http://www.controlled-trials.com/ISRCTN77145641) explored whether 90, 180 or 360 degrees of laser treatment was more effective. This study looks at effect throughout the day of 360 degrees of treatment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Eye Diseases: Glaucoma

Intervention

Randomised Clinical Trial. Randomisation to [A] 360 degree selective laser trabeculoplasty or [B] standard medical treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Intra-ocular pressure, and daytime tension curve.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2005

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with newly diagnosed early glaucoma or ocular hypertension.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Total target recruitment = 40 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2005

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Ophthalmologist
Wakefield
WF1 4EE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The Mid Yorkshire Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19106150

Publication citations

  1. Results

    Nagar M, Luhishi E, Shah N, Intraocular pressure control and fluctuation: the effect of treatment with selective laser trabeculoplasty., Br J Ophthalmol, 2009, 93, 4, 497-501, doi: 10.1136/bjo.2008.148510.

Additional files

Editorial Notes